Particle formulations and uses thereof

Abstract

Aqueous dispersions of chemically and physically stable particles for use in delivery of active pharmaceutical ingredients and processes for their production and use to enhance a biological response to an active pharmaceutical ingredient and prophylactically or therapeutically treat a subject are provided. Vaccines, wherein the active pharmaceutical ingredient is a solution of subunit vaccine antigen mixed with a colloidal dispersion of electrically charged particles and use of such vaccines in immunization are also provided.

What is claimed is: 
     
       1. A process for formulating a composition comprising an aqueous dispersion of chemically and physically stable particles having an average diameter of less than 100 μm mixed and a water-soluble or water-dispersible active pharmaceutical ingredient, said process comprising forming an aqueous dispersion of chemically and physically stable particles having an average diameter of less than 100 μm using high shear provided by an ultrasonic horn or a high-pressure homogenizer via a process free from organic solvents, said particles consisting of a hydrophobic organic material stable to aqueous hydrolysis, the hydrophobic organic material comprising carnauba wax or beeswax, which material interacts with a co-dissolved or co-dispersed active pharmaceutical ingredient, and one or more surfactants or emulsifiers selected from the group consisting of cetyltrimethylammonium bromide, cetyl pyridinium halide, chitosan, chitosan-acetate, polyetholylated stearyl alcohol, sodium dodecyl sulfate, sodium myristate and fatty acids or salts thereof and mixing said particles with a water-soluble or water-dispersible active pharmaceutical ingredient so that the water-soluble or water-dispersible active pharmaceutical ingredient is adsorbed to a surface of said particles. 
     
     
       2. The method of  claim 1  where said particles have an average diameter of less than 10 μm. 
     
     
       3. The method of  claim 1  where said particles have an average diameter of less than 1 μm. 
     
     
       4. The method of  claim 1  wherein the active pharmaceutical ingredient comprises a protein. 
     
     
       5. The method of  claim 1  wherein the active pharmaceutical ingredient comprises an antigen. 
     
     
       6. The method of  claim 1  wherein the formulated composition is a vaccine.